Two-way SMS program to spot and prevent wasting in HIV-exposed young children in Kenya

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an individually randomized, unblinded trial comparing a maternally administered malnutrition monitoring system with infant and young child feeding (MAMMS IYCF) delivered by two-way SMS to standard of care at clinics in Homa Bay and Migori counties. The trial will enroll about 600 caregiver-child pairs (children 6–24 months, HIV-exposed or living with HIV) who are not moderately or severely wasted at enrollment and who have access to a Safaricom phone. Study staff will collect baseline socioeconomic and medical histories, perform repeated anthropometry (length, weight, MUAC) on children and caregivers, and administer questionnaires about feeding knowledge and care-seeking; no biological samples are collected. Primary outcomes include incidence of malnutrition and related events (time to recovery, hospitalizations, severe malnutrition, and death), with secondary analyses of cost-effectiveness and changes in feeding behavior and trust in the health system.

Why it matters

Who can join: the full rules

Inclusion Criteria (HIV-exposed caregiver-child pairs):

* Children aged 6 to 24 months all-inclusive with a MUAC ≥ 12.5cm at the date of recruitment
* Children living with HIV or HIV-exposed uninfected children seen as outpatients in early infant detection (EID) or HIV-care clinics at the participating hospitals
* The child's caregiver is willing and able to provide informed consent
* The child's caregiver can read or write or has someone to help them read or write
* The child's caregiver is planning to remain in the catchment area with their child for \> 6 months and willing to return to the health facility for 6-month follow up visits
* The child's caregiver has access to a Safaricom phone line and provides a mobile phone number

Inclusion Criteria (healthcare workers):

\- Healthcare workers working in Homa Bay and Migori County Referral Hospitals, who have contact with pediatric inpatients

Exclusion Criteria:

* Children with moderate or severe wasting (MUAC \<12.5cm, weight-for-height z-score \<-2, or nutritional edema) at the time of eligibility screening
* Children with a congenital condition that limit feeding or syndromes that prevents age-appropriate feeding
* Child is enrolled in another study that the PI judges to compromise the aims of this study
* Child's caregiver does not pass the second training after being unable to satisfactorily complete the first MUAC training.
* Child's caregiver is under the age of 18 years.

Where it's running

• Homa Bay County Referral Hospital
  Homa Bay, Kenya Recruiting
• Migori County Referral Hospital
  Migori, Kenya Recruiting

Study contacts

• Principal investigator: Arianna R Means, PhD — University of Washington
• Study coordinator: Arianna R Means, PhD
• Email: aerubin@uw.edu
• Phone: 206-370-0225

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.